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Cytosar-U Side Effects

Generic Name: cytarabine

Note: This document contains side effect information about cytarabine. Some of the dosage forms listed on this page may not apply to the brand name Cytosar-U.

For the Consumer

Applies to cytarabine: parenteral conventional cytarabine injection, parenteral conventional cytarabine powder for injection, parenteral liposomal cytarabine injection

Side effects include:

IV, sub-Q, or IM administration of conventional cytarabine (the active ingredient contained in Cytosar-U) Myelosuppression, anorexia, nausea, vomiting, diarrhea, oral and anal inflammation or ulceration, hepatic dysfunction, fever, rash, thrombophlebitis, bleeding (all sites).

Intrathecal administration of conventional cytarabine: Nausea, vomiting, fever, transient headaches.

Intrathecal administration of liposomal cytarabine: Chemical arachnoiditis (neck rigidity, neck pain, meningism, nausea, vomiting, headache, fever, back pain, and/or CSF pleocytosis), asthenia, pain, confusion, somnolence.

For Healthcare Professionals

Applies to cytarabine: injectable powder for injection, injectable solution


Very common (10% or more): Hemorrhagic conjunctivitis, corneal disorder
Common (1% to 10%): Photophobia, burning, visual disturbance, increased lacrimation, keratitis
Uncommon (0.1% to 1%): Conjunctivitis
Frequency not reported: Blindness[Ref]

Nervous system

Very common (10% or more): Somnolence
Common (1% to 10%): Decreased level of consciousness, dysarthria, nystagmus
Uncommon (0.1% to 1%): Neurotoxicity, neuritis, dizziness, headache, peripheral neuropathy, paraplegia (with intrathecal administration)
Frequency not reported: Dizziness, neurotoxicity rash, coma, convulsion, peripheral sensory neuropathy, ataxia, tremor, coma, convulsions[Ref]


Uncommon (0.1% to 1%): Chest pain
Very rare (less than 0.01%): Arrhythmia
Frequency not reported: Pericarditis, cardiomyopathy[Ref]


Very common (10% or more): Bone marrow failure, thrombocytopenia, anemia, megaloblastic anemia, leukopenia, reticulocyte count decreased
Common (1% to 10%): Bleeding (all sites), thrombophlebitis
Frequency not reported: Reticulocytopenia, neutropenia, febrile neutropenia[Ref]


Uncommon (0.1% to 1%): Anaphylactic reaction, allergic edema[Ref]


Very common (10% or more): Sepsis, infection
Frequency not reported: Viral, bacterial, fungal, parasitic, or saprophytic infections, in any location in the body (sometimes fatal)[Ref]


Uncommon (0.1% to 1%): Injection site cellulitis, injection site thrombophlebitis
Frequency not reported: Injection site pain, injection site inflammation, injection site irritation, injection site sepsis[Ref]


Very common (10% or more): Cytarabine (the active ingredient contained in Cytosar-U) syndrome (e.g., fever, myalgia, bone pain, occasionally chest pain, exanthema, maculopapular rash, conjunctivitis, nausea, malaise)
Uncommon (0.1% to 1%): Myalgia, joint pain[Ref]


Common (1% to 10%): Anorexia, hyperuricemia[Ref]


Frequency not reported: Personality change, confusion[Ref]


Uncommon (0.1% to 1%): Urinary retention
Frequency not reported: Amenorrhea, azoospermia[Ref]


Very common (10% or more): Hepatic function abnormal
Common (1% to 10%): Liver enzymes increased
Uncommon (0.1% to 1%): Jaundice
Frequency not reported: Liver abscess, hyperbilirubinemia, hepatomegaly, Budd-Chiari-syndrome (hepatic venous thrombosis)[Ref]


Very common (10% or more): Pneumonia, acute respiratory distress syndrome, pulmonary edema
Uncommon (0.1% to 1%): Shortness of breath[Ref]


Very common (10% or more): Pyrexia[Ref]


Uncommon (0.1% to 1%): Renal dysfunction[Ref]


Very common (10% or more): Alopecia, rash
Common (1% to 10%): Skin ulceration, erythema, bullous dermatitis, vasculitis
Uncommon (0.1% to 1%): Lentigo, palmar-plantar erythrodysesthesia syndrome, urticaria, pruritus, freckling, burning pain of palms and soles
Very rare (less than 0.01%): Neutrophilic eccrine hidradenitis
Frequency not reported: Skin bleeding[Ref]


Very common (10% or more): Stomatitis, mouth ulceration, anal ulcer, anal inflammation, diarrhea, vomiting, nausea, abdominal pain
Common (1% to 10%): Necrotizing colitis
Uncommon (0.1% to 1%): Sore throat, esophagitis, esophageal ulceration, bowel necrosis
Frequency not reported: Pancreatitis, bowel necrosis, GI ulcer, pneumatosis intestinalis, peritonitis, mucosal bleeding[Ref]


1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Cytarabine (cytarabine)." Hospira Inc, Lake Forest, IL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.